009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola

What We Covered 00:44 – Ed, Brian and Meranda join the show to share their experiences in all phases of the pharmaceutical development industry 5:12 – The process of filing an Investigational New Drug (IND) and a New Drug Application (NDA) 18:54 – What it means to have ‘rest-of-world awareness’ as you author an NDA 22:37 – Ed, Brian and Meranda speak to the importance of storyboards and telling a story from the right perspective 28:55 – Ed, Brian and Meranda break down the detailed development process, including the work that Design Space InPharmatics does 39:28 – The document review process, timelines for submissions and tracking projects 49:00 – Ed, Brian and Meranda conclude the podcast and thank the audience for listening Tweetable Quotes “Filing an IND is important to get a trial started. And folks start clinical trials for a variety of reasons.” (05:43) (Ed) “Out of academia we see a lot of this very little information filed into an IND, and then very little information generated up to the point where you get to a Phase Two or Three where you see efficacy data and then suddenly you have to file an NDA.” “It’s hard to become an expert. There’s no real training. I think a lot of it is just experience. It’s going into meetings with FDA when you don’t have all the data.” “Make sure it looks good, because it does reflect on the actual data and content in there, just like anything in life.” “As the author goes through the process with the client, there’s still another piece. And that’s the publishing group.” “One way to alleviate that [stress] is to be able to give an update on any given subject or any given section at any given time.” Relevant Links Design Space InPharmatics - LinkedIn Design Space InPharmatics - Twitter Edward Narke on LinkedIn Brian Lihou on LinkedIn Meranda Parascandola on LinkedIn

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009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola is an episode from CMC Live - Chemistry, Manufacturing & Controls by DSI.

This episode is 00:50:50 long.

This episode was published on Sep 25, 2020.

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